Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis

... - Shown to be highly effective in strengthening bones and protecti... against osteoporosis-related fractures including spine and hip - R... to placebo in study published in New England Journal of Medicine - ... benefits ...

against osteoporosis-related fractures, including spine and hip
- Reclast reduced spine fractures by 70% and hip fractures by 41% compared

to placebo in study published in New England Journal of Medicine
- Unique once-yearly dosing provides potential for significant compliance

benefits

- Osteoporotic fractures affect one in two women over 50(1) and are

associated with increased morbidity, mortality and healthcare costs

EAST HANOVER, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Reclast(R)
(zoledronic acid) Injection has been approved by the US Food and Drug
Administration as the first and only once-yearly medicine for
postmenopausal osteoporosis, offering an important new approach to the
treatment of a bone disease affecting eight million women in the US(1).

Unlike oral bisphosphonate therapies that have to be taken daily,
weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous
(IV) infusion. This means with a single treatment a patient can receive a
full year's protection against the effects of osteoporosis -- a disorder
that causes bones to break easily.

"The fact that Reclast is highly effective and can be administered
once-yearly represents a major milestone in the treatment of postmenopausal
osteoporosis," said Felicia Cosman, MD, Professor of Clinical Medicine,
Columbia University.

"For the first time we can ensure women receive a full year of the
treatment they need to protect their bones," said Dr. Cosman.

The US approval comes a few weeks after the Committee for Medicinal
Products for Human Use (CHMP) issued a positive opinion recommending
approval for the medicine in the European Union, under the brand name
Aclasta(R). The European Commission generally follows the CHMP's
recommendations and is expected to issue a final decision within three
months.

The regulatory submissions were based on efficacy and safety data from
a three-year Pivotal Fracture Trial, showing that Reclast increases bone
strength and reduces fractures in areas of the body typically affected by
osteoporosis, including the hip, spine and non-spine (i.e. hip, wrist, arm,
leg, rib). Reclast is the only treatment proven to reduce fractures across
all of these key sites.

In this study involving more than 7,700 women, Reclast reduced the risk
of spine fractures by 70% and hip fractures by 41% (The New England Journal
of Medicine, May 3, 2007)(2). The reduction in spine fractures was
sustained over three years (60% in year one, 71% in year two, and 70% in
year three). Bone mineral density increased significantly in the spine by
6.7% and the hip by 6% in women on Reclast compared to placebo(2).

"Reclast has shown significant efficacy in protecting women against
fractures in all the common osteoporotic fracture sites, while
demonstrating a favorable safety profile," said James Shannon, MD, Global
Head of Development at Novartis Pharma AG. "It is our hope that this
innovative once-yearly dosing regimen will have a positive impact on the
management of this potentially devastating condition."

The need for effective treatments is pressing, with one out of every
two women over the age of 50 suffering an osteoporotic fracture in her
lifetime(1). The disease is responsible for 1.5 million fractures in the US
every year(1), some of which can have severe consequences. Approximately
20% of women over the age of 50 who suffer a hip fracture will die within
one year(1).

Osteoporotic fractures are responsible for an estimated 800,000
emergency room visits, 500,000 hospitalizations, 180,000 nursing home
placements, and 2.6 million physician visits in the US each year(3),
costing the healthcare system approximately $12.2 to 17.9 billion
annually(3).

"Osteoporosis is a serious disease affecting millions of people in this
country," said Leo Schargorodski, executive director of the National
Osteoporosis Foundation (NOF). "NOF welcomes new FDA approved treatment
options, such as Reclast, that give patients a choice when it comes to
taking their osteoporosis therapy."

Reclast/Aclasta is approved in more than 60 countries, including the
US, Canada and the EU for the treatment of Paget's disease, the second most
common metabolic bone disorder. Additional studies are ongoing to examine
the use of Reclast to prevent fractures following a hip fracture in men and
women, treatment of corticosteroid-induced osteoporosis, and male
osteoporosis.

The active ingredient in Reclast is zoledronic acid, which is also
available in a different dosage under the brand name Zometa(R) (zoledronic
acid 4 mg) Injection for use in certain oncology indications.

Reclast is contraindicated in patients with hypocalcemia (low blood
calcium) and those who are allergic to zoledronic acid. Reclast contains
the same active ingredient found in Zometa. Patients already being treated
with Zometa should not be treated with Reclast. Reclast should not be used
during pregnancy because of potential harm to the fetus. Reclast is not
recommended for use in patients with severe renal impairment (creatinine
clearance <35 mL/min) and infusion time should not be less than 15 minutes.

The most common side effects associated with Reclast are fever; pain in
the muscles, bones or joints; flu-like symptoms; and headache. These
symptoms usually occur within the first three days following Reclast
administration and usually resolve within 3 to 4 days of onset but
resolution could take up to 7 to 14 days. Patients have reported severe
bone, joint and/or muscle pain after using bisphosphonates. Osteonecrosis
of the jaw (ONJ) has been reported rarely in postmenopausal osteoporosis
patients treated with bisphosphonates. A routine oral examination should be
performed by the prescriber prior to initiation of bisphosphonate
treatment. Hypocalcemia may occur with Reclast therapy. In the Pivotal
Fracture Trial an increased number of cases of serious atrial fibrillation
were observed in women given Reclast compared to those on placebo (1.3% vs.
0.4% respectively)(2). The timing of these events suggest that they were
not related to the acute infusion. This finding has not been observed in
other zoledronic acid clinical studies and in post-marketing experience
from more than 1.5 million patients treated with Zometa.

All patients with Paget's disease should receive 1500 mg of calcium in
divided doses and 800 IU of vitamin D daily, particularly in the two weeks
following Reclast administration. It is recommended that patients with
postmenopausal osteoporosis take calcium and vitamin D supplements, if
dietary intake is not sufficient.

The foregoing press release contains forward-looking statements that
can be identified by the use of forward-looking terminology such as
"potential", "anticipated", "generally follows", "expected", "hope",
"will", or similar expressions, or by express or implied discussions
regarding potential future regulatory approvals of Reclast/Aclasta, or
potential future sales of Reclast/Aclasta. Such forward-looking statements
reflect the current views of Novartis regarding future events, and involve
known and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements. There
can be no guarantee that Reclast/Aclasta will be approved for sale, or for
any additional indications or labeling in any market, or that
Reclast/Aclasta will reach any particular level of sales. In particular,
management's expectations regarding Reclast/Aclasta could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected additional analysis of existing clinical data, and unexpected
new clinical data; competition in general; government, industry, and
general public pricing pressures; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection; as
well as the additional factors discussed in Novartis AG's Form 20-F filed
with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described herein
as anticipated, believed, estimated or expected. Novartis is providing this
information as of this date and does not undertake any obligation to update
any forward-looking statements contained in this document as a result of
new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS) -- a world leader in
offering medicines to protect health, cure disease and improve well-being.
Our goal is to discover, develop and successfully market innovative
products to treat patients, ease suffering and enhance the quality of life.
We are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with leadership
positions in these areas. In 2006, the Group's businesses achieved net
sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately
USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland,
Novartis Group companies employ more than 100,000 associates and operate in
over 140 countries around the world. For more information, please visit
http://www.novartis.com.

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